RecallDepth
Class I Terminated

grande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana Seed 80 mg, Ginko Leaf 60 mg, Saw Palmetto 100 mg, Damiana Leaf 100 mg, Ginseng Root 80 mg, Tribulus Terrestris 90 mg, Tongkat Alo 100 mg, Rhodiola Rosea 60 mg, L-Arginine 90 mg), 1-capsule packets, distributed by Grande X Ontario, CA 91745, UPC 640793555440

Company
Gadget Island, Inc
Recall Initiated
September 15, 2017
Posted
December 13, 2017
Recall Number
D-0106-2018
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
198 1-capsule packets
Firm Location
Newark, CA, United States

Reason for Recall

Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.

Distribution

Nationwide in the USA

Lot / Code Info

All Lots

Other recent Class I Drug recalls